(14 days)
The Microlife Digital Underarm Thermometer MT 18E1-1 (V932-1) is designed specifically for measuring underarm (axillary) temperatures.
Unlike regular thermometers, the unique elbow of the Digital Underarm thermometer is designed to find the " hotspot" easily and comfortably every time.
The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.
The provided document is a 510(k) Summary for a medical device cleared by the FDA, the Microlife Digital Underarm Electronic Thermometer, Model MT18E1-1 (V932-1). This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish new acceptance criteria.
Based on the provided text, the device did not undergo a study to prove it meets acceptance criteria in the way a novel AI or diagnostic device might. Instead, its acceptance was based on showing substantial equivalence to a previously cleared predicate device.
Here's an analysis of the information requested, based on the document's content:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicitly stated acceptance criteria or performance metrics derived from a new clinical study are provided. The submission focuses on substantial equivalence to a predicate device and compliance with voluntary standards for thermometers. | Not applicable. The document does not report specific device performance metrics from a new clinical study against acceptance criteria. |
| Compliance with ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | Device is compliant with ASTM E1112. |
| Compliance with IEC60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Device is compliant with IEC60601-1. |
| Compliance with IEC60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) | Device is compliant with IEC60601-1-2. |
| Compliance with ISO 10993 (Biological evaluation of medical devices) | Device is compliant with ISO 10993 (biocompatibility testing). |
| Substantial equivalence to predicate device (Micro Idea Instrument Digital Thermometer, Model MT3001/5001, K#851146) | Bench testing demonstrated that differences in characteristics do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document explicitly states "Discussion of Clinical Tests Performed: Not applicable." The acceptance was based on non-clinical tests (bench testing for standard compliance and comparison to predicate device). Therefore, there was no test set in the sense of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a digital thermometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a digital thermometer, not an algorithm. Bench testing verified the device's performance against standards and the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" was established by voluntary standards (ASTM E1112, IEC60601-1, IEC60601-1-2, ISO 10993) and the performance characteristics of the predicate device. The fundamental principle of operation (thermistor resistance change correlated to temperature) is based on established physics, which serves as the underlying scientific ground truth for temperature measurement.
8. The sample size for the training set
- Not applicable. This device is a hardware product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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/032658
SEP 1 1 2003
Exhibit #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
Microlife Intellectual Property Max Schmidheinv-Strasse 201 9435 Heerbrugg / Switzerland
Date Prepared: August 15, 2003
Contact: Mr. Gerhard Frick
2. Name of the Device:
Microlife Digital Underarm Electronic Thermometer, Model MT18E1-1 (V932-1)
3. Predicate Device Information:
Micro Idea Instrument Digital Thermometer, Model MT 3001/5001, K#851146, Microlife Corporation
Device Description: ব,
Unlike regular thermometers, the unique elbow of the Digital Underarm thermometer is designed to find the " hotspot" easily and comfortably every time.
The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.
5. Intended Use:
The Microlife Digital Underarm Thermometer MT 18E1-1 (V932-1) is designed specifically for measuring underarm (axillary) temperatures.
Comparison to Predicate Devices: 6.
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The Microlife Intellectual Property's digital underarm thermometer, Model MT18E1-1 (V932-1) is substantially equivalent to the Micro Idea Instrument Digital Thermometer. (Model MT3001/5001) K#851146.
The new model MT18E1-1 (V932-1) has the same intended use for human bodv
temperature measurement but focuses especially on underarm temperature and is similar in design to the 510(k) cleared device except for the unique elbow sensor design.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1112, as well as IEC60601-1 and IEC60601-1-2 requirements and well as ISO 10993 biocompatibility testing.
Guidance documents included the "FDA Guidance on the Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers".
8. Discussion of Clinical Tests Performed:
Not applicable.
9. Conclusions:
The Microlife Digital Underarm Thermometer has the same intended use and similar technological characteristics as the Micro Idea Instrument Digital Thermometer, (Model MT3001/5001). Moreover, bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Digital Underarm Thermometer is substantially equivalent to the predicate device.
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings and head.
SEP 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Microlife Intellectual Property GMBH C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K032658
Trade/Device Name: Microlife Model MT18E1-1 (V932-1) Digital Underarm Electronic Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 27, 2003 Received: August 28, 2003
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If /our device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Mosenkis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice reguirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runnes
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit B
of Page イ
510(k) Number (if known):
,
Device Name
Indications For Use:
Microlife Digital Underarm Thermometer MT18E1-1 (V932-1) is designed specifically for measuring underarm (axillary) temperatures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
Patria Cescente
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032658
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.